第3类:

是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。比如常见的销售xinguan实际检测盒、隐形眼镜、注射器、静脉留置针、心脏支架、呼吸机、CT、核磁共振等。

医疗器械经营许可证现为后置审批，有效期为5年。有效期届满需要延续的，依照有关行政许可的法律规定办理延续手续。

一、三类医疗器知械许可证注册所需材料

1、企业名称与经营范围，注册资本及股东出资比例，股东等身份证明;

2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;

3、质量管理文件等;

4、2个或以上医学專业或相关專业人员证书、身份证明与简历;

5、符合医疗器械经营要求的办公场地及仓库证明;

6、公司章程、股东会决议等;

7、财务人员身份证和上岗证;

 license. 1. Materials required for the registration of third III medical equipment license 1. Enterprise name and business scope, registered capital and proportion of shareholder contribution, shareholders and other identity certificates; 2. Medical device product registration certificate, supplier business license, license and authorization letter; 3. Quality management documents, etc.; 4,2 or more certificates, identification certificate and resume of medical professionals or related professionals; 5. Office space and warehouse certificate that meet the business requirements